Instrument Kit: Abutment Installation G USA

GUDID 07340152101952

Used to install the Abutment into the Fixture. Consists of the following components: Installation Handle, Installation Pin, Installation Cylinder & Installation Nut and additional standard components.

Integrum AB

Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar

• Primary Device ID: 07340152101952
• NIH Device Record Key: 4208caf5-f9fb-48a6-955c-65b1e90224c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instrument Kit: Abutment Installation G USA
• Version Model Number: 2527
• Company DUNS: 356739813
• Company Name: Integrum AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340152101952 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P190009

FDA Product Code

• PJY: Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07340152101952]

Moist Heat or Steam Sterilization

[07340152101952]

Moist Heat or Steam Sterilization

[07340152101952]

Moist Heat or Steam Sterilization

[07340152101952]

Moist Heat or Steam Sterilization

[07340152101952]

Moist Heat or Steam Sterilization

[07340152101952]

Moist Heat or Steam Sterilization

[07340152101952]

Moist Heat or Steam Sterilization

[07340152101952]

Moist Heat or Steam Sterilization

[07340152101952]

Moist Heat or Steam Sterilization

[07340152101952]

Moist Heat or Steam Sterilization

[07340152101952]

Moist Heat or Steam Sterilization

[07340152101952]

Moist Heat or Steam Sterilization

[07340152101952]

Moist Heat or Steam Sterilization

[07340152101952]

Moist Heat or Steam Sterilization

[07340152101952]

Moist Heat or Steam Sterilization

[07340152101952]

Moist Heat or Steam Sterilization

[07340152101952]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-28
• Device Publish Date: 2023-06-20

Devices Manufactured by Integrum AB

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• 07340152102126 - OPRA™ Implant System Abutment 12x78 +2: 2023-12-26 Abutment 12x78 +2
• 07340152102133 - OPRA™ Implant System Abutment 12x78 +3: 2023-12-26 Abutment 12x78 +3
• 07340152102140 - OPRA™ Implant System Abutment 12x78 +4: 2023-12-26 Abutment 12x78 +4
• 07340152102157 - OPRA™ Implant System Abutment 12x78 +5: 2023-12-26 Abutment 12x78 +5
• 07340152102164 - OPRA™ Implant System Abutment 12x78 +6: 2023-12-26 Abutment 12x78 +6
• 07340152102171 - OPRA™ Implant System Abutment 12x78 +7: 2023-12-26 Abutment 12x78 +7